BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI MATRIX POLYAXIAL SCREW 55MM THREAD LENGTH

    MDR report key: 3041658 · Received April 8, 2013

    Report

    Report Number
    2530088-2013-10389
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    September 28, 2011
    Report Date
    September 28, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MANUFACTURING EVALUATION SHOWED THAT THE CONDITION OF THE RETURNED PRODUCT SHOWS DAMAGE TO THE BONE THREADS OF THE SCREW. SOME THREADS ARE SHEERED AWAY AND OTHERS HAVE BEEN BROKEN FORMING BURRS ON THE THREAD. THE MINOR DIAMETER SHOWS WEAR MARKS NOT CONSISTENT WITH MANUFACTURING. SINCE THE THREAD PROFILE COULD NOT BE INSPECTED DUE TO THE DAMAGE TO THE THREADS, THE COMPLAINT IS CONSIDERED INDETERMINATE.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POSTERIOR TLIF, LEVEL L4-S1 THE SCRUB TECH WENT TO LOAD A 7.0 MM TI MATRIX POLYAXIAL SCREW, AND NOTICED THE BOTTOM THREE THREADS LOOKED FRAYED. SCRUB TECH SELECTED ANOTHER SCREW AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142922 7.0MM TI MATRIX POLYAXIAL SCREW 55MM THREAD LENGTH NKB SYNTHES BRANDYWINE 6594450

    Patients

    Seq Age Sex Outcome Treatment
    1